Anavex Completes Patient Enrollment for Phase 2a Alzheimer’s Trial Ahead of Schedule
NEW YORK – September 28, 2015
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 has been completed ahead of schedule. With the Phase 2a trial now fully enrolled, Anavex expects to release topline data for PART A before the end of the year.
“There has been significant interest in our Phase 2a Alzheimer’s trial and full enrollment is an important step forward. We are delighted to be ahead of schedule and thank the patients and their families for their participation,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the full ANAVEX 2-73 Phase 2a trial results and our team is excited to continue moving this clinical program forward.”
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients has enrolled 32 patients. It started in January 2015 and all the 32 patients, most who are also taking donepezil, have initiated PART A of the two-part trial.
Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 52 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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